Identity
- Trade Name
- DeRoyal FDA UDI
- Generic Name
- Epithelial-resurfacing corneal shield FDA UDI
- Device Name
- Corneal Shield 7MM Diameter FDA UDI
- Model / Reference
- 34-501 FDA UDI
- Description
- Corneal Shield 7MM Diameter FDA UDI
Identifiers
- Catalog Number
- 34-501 FDA UDI
- Primary DI / UDI-DI
- 00749756142731 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Epithelial-resurfacing corneal shield FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Epithelial-resurfacing corneal shield
DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SOFT SHIELD® Collagen Shields — OASIS Medical, Inc. · Class I
- CORNEAL SHIELD — Cynosure, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Deroyal Industries, Inc.
Sources (1)
- FDA UDI b63a3beb-7ae4-433b-b55a-0314513f7776 35 fields · synced Jun 8, 2026